NCT02148536

Brief Summary

To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

May 21, 2014

Last Update Submit

August 28, 2018

Conditions

Hepatopulmonary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Alveolar-arterial oxygen gradient (PA-a,O2)

    12 Weeks

Secondary Outcomes (2)

  • Macroaggregated albumin (MAA) shunt fraction

    12 Weeks

  • Exhaled nitric oxide (eNO)

    12 Weeks

Study Arms (1)

HPS-TIPS group

Procedure: Transjugular intrahepatic portosystemic shunt

Interventions

Transjugular intrahepatic portosystemic shuntPROCEDURE
HPS-TIPS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cirrhotic patients with hepatopulmonary syndrome undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital.

You may qualify if:

  • Presence of cirrhosis
  • Alveolar-arterial oxygen gradient ≥ 15 mm Hg (≥ 20 mm Hg for age \> 64 years)
  • Positive contrast-enhanced echocardiography

You may not qualify if:

  • Age of less than 18 years
  • Intrinsic cardiopulmonary disease
  • Malignancy
  • Active infection
  • Pregnancy
  • Previous shunt therapy
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan university

Chengdu, Sichuan, 610041, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

aterial and venous blood

MeSH Terms

Conditions

Hepatopulmonary Syndrome

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 28, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

CN(1)